Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01358955
NCT01358955CompletedNot Applicable

A Multicenter, Randomized Trial to Assess Efficacy of Home-based and Group Cognitive Intervention Programs in Amnestic Mild Cognitive Impairment

Inha University Hospital18 sites in 1 country293 target enrollmentStarted: March 1, 2011Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
293
Locations
18
Primary Endpoint
Modified Alzheimer's Disease Assessment Scale-Cognitive subscale(ADAS-cog)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

  • There will be a significant difference in cognitive function between cognitive intervention group (group therapy) and a wait list control group.
  • There will be a significant difference in cognitive function between a home-based cognitive intervention group and a wait list control group.

Detailed Description

The change of Modified ADAS-cog score from the baseline to post-intervention will be compared between the cognitive intervention group and wait list control group.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
50 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •50 to 85 years of age
  • •memory complaint corroborated by a participant and an informant
  • •delayed recall score on the Seoul Verbal Learning Test (SVLT) below 1.0 standard deviations from the mean of the age and education-normative values among the Korean population
  • •Global CDR score is 0.5, Memory CDR score is 0.5 or
  • •above 1.5 standard deviations from the mean of normative data of the respective age- and education-matched population on the Korean Mini-Mental State Examination
  • •normal functional activities
  • •not diagnosed with dementia
  • •Modified Hachinski Ischemic Score (HIS): 0-4
  • •brain magnetic resonance imaging or CT showing no clinical evidence of other diseases (i.e., normal pressure hydrocephalus, brain tumor, cerebrovascular disease) capable of producing cognitive impairment.
  • •Subjects are also required to have a reliable caregiver who meet the patient at least once a week and is sufficiently familiar with the patient to provide the investigator with accurate information.
  • •He/She can read and write
  • •written informed consent

Exclusion Criteria

  • •any patient who were involved in other clinical trials or treated with experimental drug within 4 weeks
  • •any patients with any severe or unstable medical disease that may prevent the patient from completing all study requirements (i.e., unstable or severe asthma or cardiovascular disease, active gastric ulcer, severe hepatic or renal disease)
  • •any patients with clinically significant laboratory abnormalities such as an abnormal thyroid function test, abnormal low level of vitamin B12 or folate, or positive venereal disease research laboratory test
  • •any patients with any primary neurodegenerative disorder or psychiatric disorder other than AD (i.e., Parkinson's disease, schizophrenia, or major depressive disorder)
  • •any patients with any history of drug or alcohol addiction during the past 10 years
  • •any hearing or visual impairment that can disturb the efficient evaluation of the patient

Arms & Interventions

Wait list Control

No Intervention

They will participate in cognitive intervention after ending this study.

Group cognitive intervention

Active Comparator

The cognitive training will be administered twice a week for 12 weeks, located in hospital-based outpatient memory clinics. Each session will last approximately 90 minutes. The cognitive training programs will be offered in group sessions consisted of 5 participants.

Intervention: group cognitive intervention (Other)

Home-based cognitive intervention

Active Comparator

The participants will do their homework for 30 minutes every business days for 12 weeks.

Intervention: Home-based cognitive intervention (Other)

Outcomes

Primary Outcomes

Modified Alzheimer's Disease Assessment Scale-Cognitive subscale(ADAS-cog)

Time Frame: postintervention, 12 weeks follow-up, and 24 weeks follow-up

Secondary Outcomes

  • story recall test(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
  • Digit span forward and backward(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
  • Word fluency test(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
  • color-word stroop test(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
  • Digit symbol test(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
  • prospective memory test(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
  • Mini-Mental State Examination(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
  • CDR-SB(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
  • K-AD8(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
  • PRMQ(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
  • MMQ-Strategy(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
  • QOL-AD(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
  • Geriatric Depression Scale-short form(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
  • Bayer ADL(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
  • CGA-NPI(postintervention, 12 weeks follow-up, and 24 weeks follow-up)
  • Subjective cognitive assessment(postintervention, 12 weeks follow-up, and 24 weeks follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Chul Soo Kim

Professor

Inha University Hospital

Study Sites (18)

Loading locations...

Similar Trials

Completed
Not Applicable
TVT-O versus TVT-S Trial.1. Urinary incontinence (NLD: urine incontinentie)<br /> 2. stress incontinence<br />3. prosthesis<br />4. implants<br />5. TVT<br />6. TVT-o<br />7. TOT<br />8. TVT-s.
NL-OMON23119Jan-Paul W.R. Roovers, MD, PhD , Academisch Medisch Centrum, Amsterdam, the NetherlandsPiet Hinoul, MD, Ziekenhuis Oost Limburg, Genk, Belgium200
Unknown
Not Applicable
Repetitive Transcranial Magnetic Stimulation in Patients With Alzheimer DiseaseTranscranial Magnetic StimulationAlzheimer Disease
NCT03270137Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente19
Completed
Not Applicable
A multi centre study to determine the efficacy and patient acceptability of scalp cooling in the prevention of docetaxel-induced hair loss.Hair loss
NL-OMON26657eids Universitair Medisch Centrum in Leiden260
Completed
Early Phase 1
Cognitive Remediation and Functional Skills Training in SchizophreniaSchizophreniaSchizoaffective Disorder
NCT01175642National Alliance for Research on Schizophrenia and Depression75
Completed
Not Applicable
Effect of Individual Cognitive Stimulation on Memory and Executive Function in Older Adults With Alzheimer's DiseaseNeurocognitive DisordersCognitive DeclineCognitive ImpairmentCognitive DysfunctionDementia
NCT05433493Rsocialform - Geriatria, Lda142